*ES0139.1* February 13, 2024 ENGROSSED SENATE BILL No. 139 _____ DIGEST OF SB 139 (Updated February 13, 2024 11:01 am - DI 147) Citations Affected: IC 16-18; IC 16-46. Synopsis: Psilocybin treatment program. Establishes the therapeutic psilocybin research fund, administered by the Indiana department of health (state department), to provide financial assistance to research institutions in Indiana to study the use of psilocybin to treat mental health and other medical conditions. Sets forth clinical study requirements. Requires a research institution that receives a grant to conduct a clinical study to prepare and submit a report to the interim study committee on public health, behavioral health, and human services, the state department, and the division of mental health and addiction. Effective: Upon passage. Charbonneau, Johnson T, Busch, Yoder, Pol Jr., Randolph Lonnie M (HOUSE SPONSORS — CARBAUGH, TESHKA, MOED, GARCIA WILBURN) January 8, 2024, read first time and referred to Committee on Health and Provider Services. January 18, 2024, amended, reported favorably — Do Pass; reassigned to Committee on Appropriations. February 1, 2024, amended, reported favorably — Do Pass. February 5, 2024, read second time, ordered engrossed. Engrossed. February 6, 2024, read third time, passed. Yeas 47, nays 1. HOUSE ACTION February 12, 2024, read first time and referred to Committee on Public Health. February 13, 2024, amended, reported — Do Pass. Referred to Committee on Ways and Means pursuant to Rule 127. ES 139—LS 6465/DI 147 February 13, 2024 Second Regular Session of the 123rd General Assembly (2024) PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana Constitution) is being amended, the text of the existing provision will appear in this style type, additions will appear in this style type, and deletions will appear in this style type. Additions: Whenever a new statutory provision is being enacted (or a new constitutional provision adopted), the text of the new provision will appear in this style type. Also, the word NEW will appear in that style type in the introductory clause of each SECTION that adds a new provision to the Indiana Code or the Indiana Constitution. Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts between statutes enacted by the 2023 Regular Session of the General Assembly. ENGROSSED SENATE BILL No. 139 A BILL FOR AN ACT to amend the Indiana Code concerning health and to make an appropriation. Be it enacted by the General Assembly of the State of Indiana: 1 SECTION 1. IC 16-18-2-143, AS AMENDED BY P.L.1-2010, 2 SECTION 69, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE 3 UPON PASSAGE]: Sec. 143. (a) "Fund", for purposes of IC 16-26-2, 4 has the meaning set forth in IC 16-26-2-2. 5 (b) "Fund", for purposes of IC 16-31-8.5, has the meaning set forth 6 in IC 16-31-8.5-2. 7 (c) "Fund", for purposes of IC 16-41-39.4, refers to the childhood 8 lead poisoning prevention fund established by IC 16-41-39.4-3.1. 9 (d) "Fund", for purposes of IC 16-41-39.8, refers to the lead trust 10 fund established by IC 16-41-39.8-7. 11 (e) "Fund", for purposes of IC 16-46-5, has the meaning set forth in 12 IC 16-46-5-3. 13 (f) "Fund", for purposes of IC 16-46-12, has the meaning set forth 14 in IC 16-46-12-1. 15 (g) "Fund", for purposes of IC 16-41-42.2, has the meaning set forth 16 in IC 16-41-42.2-2. 17 (h) "Fund", for purposes of IC 16-35-8, has the meaning set forth in ES 139—LS 6465/DI 147 2 1 IC 16-35-8-2. 2 (i) "Fund", for purposes of IC 16-46-17.5, has the meaning set 3 forth in IC 16-46-17.5-1. 4 SECTION 2. IC 16-18-2-296.4 IS ADDED TO THE INDIANA 5 CODE AS A NEW SECTION TO READ AS FOLLOWS 6 [EFFECTIVE UPON PASSAGE]: Sec. 296.4. "Psilocybin", for 7 purposes of IC 16-46-17.5, has the meaning set forth in 8 IC 16-46-17.5-2. 9 SECTION 3. IC 16-46-17.5 IS ADDED TO THE INDIANA CODE 10 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE 11 UPON PASSAGE]: 12 Chapter 17.5. Therapeutic Psilocybin Research 13 Sec. 1. As used in this chapter, "fund" refers to the therapeutic 14 psilocybin research fund established by section 3 of this chapter. 15 Sec. 2. (a) As used in this chapter, "psilocybin" means a 16 naturally occurring psychedelic prodrug compound that is 17 produced by fungi, including members of the genus psilocybe. 18 (b) The term includes psilocin. 19 Sec. 2.5. As used in this chapter, "research institution" refers to 20 an organization that meets all of the following: 21 (1) Has an academic institution that operates an institutional 22 review board (IRB) that oversees research. 23 (2) Publishes the results of previous clinical trials in peer 24 reviewed publications. 25 (3) Has access to a clinical research center and the center's 26 resources, including research dedicated medical staff. 27 Sec. 3. The therapeutic psilocybin research fund is established 28 for the purpose of providing financial assistance to research 29 institutions in Indiana to study, in accordance with the 30 requirements established in section 6 of this chapter, the use of 31 psilocybin to treat mental health and other medical conditions. 32 Sec. 4. (a) The fund shall be administered by the state 33 department. 34 (b) The expenses of administering the fund shall be paid from 35 money in the fund. 36 Sec. 5. (a) The fund consists of: 37 (1) money received from state or federal grants or programs; 38 and 39 (2) gifts, money, and donations received from any other 40 source, including transfers from other funds or accounts. 41 (b) The treasurer of state shall invest the money in the fund not 42 currently needed to meet the obligations of the fund in the same ES 139—LS 6465/DI 147 3 1 manner as other public money may be invested. Interest that 2 accrues from these investments shall be deposited in the fund. 3 (c) Money in the fund at the end of a state fiscal year does not 4 revert to the state general fund. 5 (d) Money in the fund is continuously appropriated for purposes 6 of this chapter. 7 Sec. 6. (a) A research institution in Indiana may apply to the 8 state department to receive financial assistance from the fund to 9 conduct one (1) or more clinical studies to evaluate the efficacy of 10 psilocybin as an alternative treatment for mental health and other 11 medical conditions, including the following: 12 (1) Posttraumatic stress disorder, with a focus on treating the 13 disorder in combat veterans and first responders. 14 (2) Anxiety. 15 (3) Depression. 16 (4) Bipolar disorder. 17 (5) Chronic pain. 18 (6) Migraines. 19 (7) Alcohol use disorder. 20 (8) Tobacco use disorder. 21 (b) In conducting a clinical study under this section, a research 22 institution that receives a grant under this chapter shall do the 23 following: 24 (1) Include veterans and first responders in the study sample. 25 (2) Evaluate and determine whether psilocybin is an effective 26 treatment for mental health and other medical conditions 27 described in subsection (a). 28 (3) Compare the efficacy of psilocybin as a treatment for 29 mental health and other medical conditions described in 30 subsection (a) with the efficacy of other current treatment 31 options for mental health and other medical conditions 32 described in subsection (a). 33 (4) Before entering the study, require each participant to 34 undergo a mental health evaluation. 35 Sec. 7. After a research institution that receives a grant under 36 this chapter completes and finalizes a study under this chapter, a 37 research institution shall prepare and submit a report 38 summarizing the results of the study and any recommendations for 39 legislation to the following: 40 (1) The interim study committee on public health, behavioral 41 health, and human services established by IC 2-5-1.3-4 in an 42 electronic format under IC 5-14-6. ES 139—LS 6465/DI 147 4 1 (2) The state department. 2 (3) The division of mental health and addiction. 3 Sec. 8. Not later than July 1, 2024, the state department shall 4 establish a process to administer the fund and process applications 5 under this chapter. 6 SECTION 4. An emergency is declared for this act. ES 139—LS 6465/DI 147 5 COMMITTEE REPORT Madam President: The Senate Committee on Health and Provider Services, to which was referred Senate Bill No. 139, has had the same under consideration and begs leave to report the same back to the Senate with the recommendation that said bill be AMENDED as follows: Page 2, between lines 18 and 19, begin a new paragraph and insert: "Sec. 2.5. As used in this chapter, "research institution" refers to an organization that meets all of the following: (1) Has an academic institution that operates an institutional review board (IRB) that oversees research. (2) Publishes the results of previous clinical trials in peer reviewed publications. (3) Has access to a clinical research center and the center's resources, including research dedicated medical staff.". Page 3, line 9, after "institution" insert "that receives a grant under this chapter". Page 3, line 21, after "institution" insert "that receives a grant under this chapter". and when so amended that said bill do pass and be reassigned to the Senate Committee on Appropriations. (Reference is to SB 139 as introduced.) CHARBONNEAU, Chairperson Committee Vote: Yeas 11, Nays 0. _____ COMMITTEE REPORT Madam President: The Senate Committee on Appropriations, to which was referred Senate Bill No. 139, has had the same under consideration and begs leave to report the same back to the Senate with the recommendation that said bill be AMENDED as follows: Delete the title and insert the following: A BILL FOR AN ACT to amend the Indiana Code concerning health and to make an appropriation. Page 2, line 36, delete "of the following:" and insert "of:". Page 2, delete lines 37 through 39, begin a new line block indented and insert: ES 139—LS 6465/DI 147 6 "(1) money received from state or federal grants or programs; and (2) gifts, money, and donations received from any other source, including transfers from other funds or accounts.". Page 3, between lines 3 and 4, begin a new paragraph and insert: "(d) Money in the fund is continuously appropriated for purposes of this chapter.". and when so amended that said bill do pass. (Reference is to SB 139 as printed January 19, 2024.) MISHLER, Chairperson Committee Vote: Yeas 14, Nays 0. _____ COMMITTEE REPORT Mr. Speaker: Your Committee on Public Health, to which was referred Senate Bill 139, has had the same under consideration and begs leave to report the same back to the House with the recommendation that said bill be amended as follows: Page 3, between lines 18 and 19, begin a new line block indented and insert: "(7) Alcohol use disorder. (8) Tobacco use disorder.". and when so amended that said bill do pass. (Reference is to SB 139 as printed February 2, 2024.) BARRETT Committee Vote: yeas 12, nays 1. ES 139—LS 6465/DI 147